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Completed

NCT Number: NCT05769361

Training Programs Effects on Strength and Balance in Older Adults

Ageing involves several physiological changes such as loss of muscle mass, muscle strength, and alteration of balance control mechanisms. Consequently, there is an increased fall risk that can lead the older adult to a reduced self-sufficiency in daily living activities. Investigating the role of different physical activities to counteract the age-related declines deserves attention. The present study aimed to evaluate the effects of two trainings performed with and without unstable devices, on dynamic balance control and lower limb strength compared to a control group that received no intervention.

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Key information

Conditions

Fall

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Exercise Lab, DSB, University of Padova

Padova, 35131, Italy

About this study

The a-priori power analysis calculation reported a total sample size of 51 participants. We decided to increase the sample size of approximatively 20% hypothesizing an increment of drop-outs due to the not completely solved COVID-19 pandemic at the time of the study.

In this single-blinded randomized controlled study, both intervention groups received 24 training sessions of 45 minutes each, twice a week for 12 weeks.The two intervention groups and the control group were tested at the baseline (T0), after six weeks (T1), and after twelve weeks (T2).

Subjects of the intervention groups had to complete at least 21 out of 24 training sessions. Moreover, all subjects had to complete all the assessments. Otherwise, they were completely excluded from the data analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • self-sufficiency in daily living activities;
  • aged between 65 and 85 years.

Exclusion criteria

  • non-corrected sight disorders
  • neurological disorders
  • regular assumption of drugs that can interfere with normal cognitive functioning
  • pathologies that contraindicate physical activity practice

Treatment and study plan

UNST

Behavioral

Strength and balance training using different destabilizing devices

ST

Behavioral

Strength and balance training over firm surfaces

Primary outcomes

  1. Center of Pressure (CoP) Unit Path

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:

    • The mean velocity of the CoP measured in cm∙s-1 (Unit Path) over a 2.5-second time window from the beginning of the perturbation;

  2. Center of Pressure (CoP) Area95

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:

    • The area of the 95th percentile confidence ellipse of the CoP measured in cm2 (Area95) over a 2.5-second time window from the beginning of the perturbation.

  3. Center of Pressure (CoP) First Peak

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:

    • First peak (FP) as the difference in centimeters between the peak reached by the CoP displacement after the external perturbation and the mean value of the anterior-posterior CoP displacement before the perturbation.

  4. Center of Pressure (CoP) Maximal Oscillation

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:

    • Maximal oscillation of the CoP anterior-posterior displacement as the sum in centimeters of the absolute values of FP and the subsequent peak.

  5. Center of Pressure (CoP) Post Perturbation Variability

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test:

    • The standard deviation (SD) of the CoP anterior-posterior displacement over a 2.5-second time window from the beginning of the perturbation as the post perturbation variability (PPV), measured in centimeters.

  6. Lower limb isometric strength

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    Isometric quadriceps maximal strength (Newton) measured with an instrumented chair. Specifically, a load cell is placed perpendicular to the subject's shank and collects the force in Newton expressed by the subject while sitting on the chair. The knee angle during the maximal effort is fixed at 90 degrees.

Secondary outcomes

  1. Timed Up and Go (TUG) test

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    Stand up from a chair, walk at the preferred pace to a cone at 3 meters, turn around, and walk back to the chair to sit down. The outcome is the time measured in seconds to complete the test.

  2. 10-meter walking test

    Time frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

    Walking 20 meters in a straight line at the preferred speed. The outcome is the time measured in seconds to complete the distance from the 5th to the 15th meter.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Effect of a 12-week Training Program With Unstable Devices on Strength and Dynamic Balance in Older Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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